Boehringer Ingelheim recently announced the results of a subgroup analysis of the cardiovascular (CV) outcome trial CAROLINA. This subgroup analysis focuses on Asian adults with type 2 diabetes who have an increased risk of CV. The results showed that linagliptin (trade name: Trajenta®) did not increase CV risk in Asian population compared to glimepiride, and the results were consistent with the results of the entire CAROLINA study population. The results of this Asian subgroup analysis have been published in Diabetology International.
In recent years, the prevalence of type 2 diabetes in Asia has risen rapidly. In 2019, the International Diabetes Federation (IDF) estimates that there are 463 million diabetics worldwide, of which more than half (251 million) are in Southeast Asia and the Western Pacific. The pre-determined CAROLINA study subgroup analysis released this time included 933 Asian adult patients, accounting for 15.5% of the study population (6033 cases).
The subgroup analysis showed that among Asian patients in the study, linagliptin had a lower incidence of hypoglycemia and a lower risk of weight gain than glimepiride. The specific data are: (1) 13.1% of Asian patients receiving linagliptin developed hypoglycemia of any severity, compared with 42.1% of Asian patients receiving glimepiride. (2) Patients treated with linagliptin showed a moderate weight loss, compared with glimepiride, the average difference was -1.82 kg.
The CAROLINA study and the CARMELINA study constituted the 2 CV outcome trials of linagliptin and provided one of the most comprehensive data sets for the long-term safety of DPP-4 inhibitors. The results of the subgroup analysis of the CARMELINA study were published in Diabetology International in October 2019. The data showed that among Asian adults with type 2 diabetes with high risk of heart and/or kidney disease, linagliptin compared with placebo did not Increase the risk of CV or kidney events. These results are consistent with the results in the entire CARMELINA study population.
Waheed Jamal, M.D., Boehringer Ingelheim’s vice president and head of cardiometabolic medicine, said: “When the CARMELINA and CAROLINA trial results were first published, the data confirmed the long-term safety of linagliptin in a wide range of patients with type 2 diabetes. These target specific regions. Subgroup analysis will give clinicians confidence in choosing the most appropriate hypoglycemic drug for patients. The subgroup analysis of the 2 studies proves the cardiovascular and renal safety of linagliptin in a wide range of Asian type 2 diabetes adults ."
Trajenta® (linagliptin) was developed and commercialized by the Boehringer Ingelheim and Eli Lilly Alliance. The drug is a once-daily DPP-4 inhibitor that can effectively reduce blood sugar levels in adults with type 2 diabetes. When doctors prescribe Ou Dangning for adults with type 2 diabetes, they do not need to consider their age, course of disease, ethnicity, body mass index (BMI), liver function, and kidney function. Among the DPP-4 inhibitors currently on the market worldwide, Oudanning has the lowest renal excretion rate.